The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Igm Flex Reagent Cartridge.
| Device ID | K990553 |
| 510k Number | K990553 |
| Device Name: | IGM FLEX REAGENT CARTRIDGE |
| Classification | Radioimmunoassay, Immunoglobulins (g, A, M) |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 ROUTE 896, GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DADE BEHRING, INC. P.O. BOX 6101 ROUTE 896, GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | CFQ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-22 |
| Decision Date | 1999-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005732 | K990553 | 000 |